MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	6530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 85-95% stenosed target lesion was located in the left anterior descending artery.A 8mm x 3.50mm nc quantum apex balloon catheter was advanced for dilatation.However, during the procedure, the shaft was reported to be damaged.The procedure was completed with a different device.There were no patient complications reported.It was further reported that the shaft was broken.
Event or Problem Description
It was reported that shaft break occurred.The 85-95% stenosed target lesion was located in the left anterior descending artery.A 8mm x 3.50mm nc quantum apex balloon catheter was advanced for dilatation.However, during the procedure, the shaft was reported to be damaged.The procedure was completed with a different device.There were no patient complications reported.It was further reported that the shaft was broken.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.At 45cm from the strain relief, the hypotube of the device was kinked.There was a separation of the hypotube 46.6cm from the strain relief.The separated ends were jagged and ovaled in shape indicating the device was kinked prior to separation.At 1.3cm distal from the separation, the hypotube was kinked.The balloon was tightly folded and there was no evidence of fluid within the device.The tip of the device was severely damaged.Product analysis confirmed the reported break as there was separation to the device.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14463230
• Report Number: 2134265-2022-05766
• Device Sequence Number: 4904227
• Product Code: LOX
• UDI-Device Identifier: 08714729783176
• UDI-Public: 08714729783176
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2025
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0028748415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown